Tris Pharma, Inc.: oxybate

The exposure-response (E-R) analysis submitted by the Applicant relied on aggregated exposures (e.g., AUCinf, Cmax, and dose), assuming that the shape of PK profile has no effect on clinical response.

Section 505-1 of the Federal Food, Drug, and Cosmetic Act (FDCA) authorizes FDA to require the submission of a risk evaluation and mitigation strategy (REMS) if FDA determines that such a strategy is necessary to ensure that the benefits of the drug outweigh the risks [section 505-1 (a)].

If you do not have a conditionally acceptable proprietary name, you may submit a Request for Proprietary Name Review to your IND.

The results of the human factors (HF) validation study demonstrated several use errors, close calls, and use difficulties with critical tasks that may result in harm.

1. During a recent inspection of the Tris Pharma, Inc. (FEI: 3004712471) manufacturing facility for this application, our field investigator conveyed deficiencies to the representative of the facility.

Satisfactory resolution of these deficiencies is required before this application may be approved.

We note the size of the established name has been increased on the revised container labels submitted on July 12, 2018. However, the established name is now too prominent relative to the proprietary name.